Kornimate/medical-research-clean huggingface dataset:
allogeneic ipsc-derived cardiomyocyte therapy in patients with worsening ischemic heart failure

Conditions: Ischemic Heart Failure; Chronic Heart Failure

Summary: this study is designed to evaluate the safety and efficacy of allogeneic induced pluripotent cell derived cardiomyocytes (ipsc-cms) in treating patients with worsening ischemic heart failure undergoing coronary artery bypass graft surgery. after screening, ipsc-cms will be administrated intramyocardially in consented and eligible patients undergoing open-chest cabg surgery and the estimated population size for the study will be 32 patients.


Eligibility criteria:
inclusion criteria: * aged 35-75 (including 35 and 75). * signed the informed consent form (icf). * have chronic left ventricular dysfunction. * have nyha class iii-iv cardiac function even after improved medication for the treatment of advanced chronic heart failure. * have indications for coronary artery bypass grafting. * lvef \< 40% as determined by echocardiogram (data collected up to 6 months prior to inclusion evaluation are valid; data collected within 1 month since a myocardial infarction are invalid). * weakening or absence of segmental regional wall motion as determined by standard imaging exclusion criteria: * pra ≥ 20% or dsa-positive * patient received icd transplantation, crt or similar treatment. * patients with valvular heart disease or received heart valvular disease * patients received treatment of percutaneous transluminal coronary intervention (pci) * patients with atrial fibrillation * patients previously suffered sustained ventricular tachycardia or sudden cardiac death. * baseline glomerular filtration rate \<30ml/min/1.73m2. * liver dysfunction, as evidenced by enzymes (ast and alt) greater than three times the uln. * hematological abnormality: a hematocrit \<25% as determined by hct, white blood cell\<2500/ul or platelet values \<100000/ul without another explanation. * known, serious radiographic contrast allergy, penicillin allergy, streptomycin allergy. * coagulopathy (inr\>1.3) not due to a reversible cause. * contra-indication to performance of a mri scan. * recipients of organ transplant. * clinical history of malignancy within 5 years (patients with prior malignancy must be disease free for 5 years). * non-cardiac condition that limits lifespan \<1 year. * on chronic therapy with immunosuppressant medication, such as glucocorticoid and tnfα antagonist. * patients allergy to or cannot use immunosuppressant. * serum positive for hiv, hbv, hcv, tp. * currently enrolled other investigational therapeutic or device study. * patients who are pregnant or breast feeding. * other conditions that researchers consider not suitable to participate in this study.
measurement of stress during anesthesia with "pain detector" on patients receiving atropine

Conditions: Hemorrhoids; Fissure in Ano

Summary: 24 patients randomly divided into two groups, one of the groups receiving atropine in addition to the planned anaesthesia. skin conductance parameters to be compared between the two groups.

skin conductance (sc), in terms of numbers of skin conduction fluctuations (nscf), amplitude and mean skin conductance level, reflect the activity in the sympathetic postganglionic cholinergic fibers which innervate the palmar and plantar sweat glands. skin conductance, especially numbers of skin conductance fluctuations, may be a promising tool to monitor anesthesia. atropine, an anticholinergic agent, acts as an antagonist on the muscarinic receptors of the sweat glands and inhibits their secretion in a dose-dependent way. the aim of this study was to find out to what degree sc is influenced by i.v. administration of atropine. study hypothesis: sc is not influenced by i.v. administration of atropine.

Eligibility criteria:
inclusion criteria: * patients in asa-group 1-2 * operations (anal fissures, anal fistulas and haemorrhoids) lasting for less than one hour * informed consent * bmi \<30 exclusion criteria: * patients using any medication known to influence the autonomous nervous system * patients with contraindications to atropine (e.i. fibrillation, glaucoma ect) * bmi \>30 * pregnancy

Keywords: galvanic skin response anesthesia atropine
an observational study of yondelis®+pld for the treatment of patients with platinum-sensitive relapse of ovarian cancer

Conditions: Recurrent Ovarian Cancer

Summary: clinical trials are, due to the inclusion and exclusion criteria, accomplished with defined patient groups, which are not representative for the whole patient population. especially elderly patients and patients with co-morbidities are underrepresented in clinical trials. this non-interventional study will examine the efficiency and toxicity of the yondelis® + pld combination therapy in a general patient population to evaluate if the data collected in the clinical trials can be assigned to a general patient population.

yondelis® (trabectedin) was approved (in combination with pld) in the european community in december 2009 for the treatment of platinum-sensitive ovarian cancer relapse. based on the outcomes of study ova-301, this non-interventional study will investigate the role of a platinum-free treatment regimen in patients with progressive ovarian cancer relapsing \> 6 months after completing previous platinum-based chemotherapy. in particular, this study aims at collecting the "real-life" data with regard to the response and the influence of the mentioned therapy on the "tumor related events", to objectify the value of palliative care.

Eligibility criteria:
inclusion criteria: * women age \>18, no upper limit * patients with relapsed platinum-sensitive ovarian cancer * before inclusion in the nis written informed consent must be given exclusion criteria: * according to summary of product characteristics
study of shr-1209 in the treatment of hypercholesterolemia and hyperlipidemia ⅲ stage

Conditions: Primary Hypercholesterolemia; Mixed Hyperlipemia

Summary: the study is ongoing to evaluate the efficacy and safety of shr-1209 in patients with hypercholesterolemia and hyperlipemia.


Eligibility criteria:
inclusion criteria: 1. age ≥18 and ≤80 on the date of signing the informed consent, male or female; 2. fasting ldl-c was ≥2.6mmol/l and \<4.9mmol/l at screening and randomization； 3. those who understand the study procedures and methods, volunteer to participate in the study, and sign the informed consent in person. exclusion criteria: 1. have the following diseases or treatment history :(1) have known allergic reaction to experimental drugs, or have severe allergic reaction to other antibody drugs;(2) previous diagnosis of cardiac function as defined by the new york heart association (nyha) grade iii-iv; 2. any of the laboratory indicators met the following criteria at screening or at random :(1) alanine aminotransferase (alt) or aspartate aminotransferase (ast) exceeding 2 times the upper limit of normal (uln), or total bilirubin exceeding 1.5 times the upper limit of normal (uln);(2) creatine kinase (ck) exceeds 3 times the upper limit of normal value (uln); 3. general conditions :(1) the investigator judged that subcutaneous injection was not appropriate;(2) fertile female subjects who did not use contraception within 4 weeks before screening;or male or female subjects who do not agree to use high-efficiency contraceptives during the trial and for 24 weeks after the last dosing;(3) women who are pregnant or lactating. 4. the investigator determines that the subjects have poor compliance or have any factors that may prevent them from participating in the study, including, but not limited to, the study placing the subjects at unacceptable risk or possibly interfering with the study results.
safety of ibuprofen after major orthopaedic surgeries

Conditions: Pain, Acute; Hip Arthropathy; Knee Arthropathy; Safety Issues; Analgesia; Analgesic Adverse Reaction; Postoperative Pain; Postoperative Complications

Summary: safety of an eight-day treatment with ibuprofen after primary hip and knee arthroplasties.

hip and knee arthroplasty surgeries are some of the most frequently performed planned procedures in the western world. multimodal analgesic treatment is the leading analgesic treatment principle, with nsaids as an essential part. ibuprofen, the most frequently prescribed nsaid, is effective in reducing acute postoperative pain. however, ibuprofen may be associated with various serious adverse events, including death, cardiovascular morbidity, gastrointestinal ulcer, and renal impairment. the balance between beneficial and harmful effects of a short-term postoperative treatment with ibuprofen after elective hip and knee arthroplasty is unknown. objectives: to assess the adverse events of an eight-day treatment of postoperative pain with ibuprofen in patients undergoing elective primary hip or knee arthroplasty. intervention: the participants will be randomized in two groups: a) oral ibuprofen 400 mg 3 times daily for eight days. b) identical oral placebo 3 times daily for eight days. design and trial size: perisafe is a randomized, placebo-controlled multicentre trial with centralized computer-generated allocation sequence and allocation concealment with unknown block size. patients, investigators, assessors, caregivers, data-managers, writers of the manuscript, and statisticians will be blinded. a total of 2904 eligible patients are needed to detect or discard an effect corresponding to a relative risk reduction of 1/3 with an acceptable risk of type i error of 5 % and of type ii error of 20 %, and a proportion of the composite outcome of serious adverse events of 8% in the experimental group. sub-studies: * one-year follow-up on the composite primary outcome. * subgroup analysis on predictors of chronic pain and opioid consumption at 90-days, and one-year after surgery. * coherence of preoperative use of diuretics, ace-inhibitors or angiotensin-ii-antagonists and postoperative risk of renal failure.

Eligibility criteria:
inclusion criteria: * patients scheduled for elective primary hip and knee arthroplasty. * age ≥ 18 years. * planned postoperative treatment with nsaid. * negative pregnancy test for women in the fertile age. * informed consent. exclusion criteria: * unable to understand or speak danish. * allergy to or contraindications against ibuprofen.

Keywords: perisafe hip arthroplasty knee arthroplasty postoperative pain analgesia safety non-steroidal anti-inflammatory drugs
biomarkers in seizure to predict recurrence and severe outcomes

Conditions: Seizures; S-100b Protein; Copeptin

Summary: we study the hypothesis that combination of proteine s100 beta and copeptin within normal ranges can rule out seizure recurrences and severe outcome, and allow early discharge from the emergency department

prospective study for a 12 month period in paris (france) and london (uk). inclusion criteria : * seizure within 24h of attendance to an emergency department (ed) * or seizure in the ed exclusion criterie : * pregnancy * prisoneer primary endpoint : - recurrence of seizure, hospitalisation more than 24 hours or death within seven days secondary endpoint : * hospital free days at day 7 and day 28 * death, icu admission, or neurosurgical intervention at day 7 and day 28 * return visit to the ed or re admission at day 7 and day 28 data collection: * demographics * past medical history, medication * vital signs (heart rate, temperature, pulse oxymetry, blood pressure, gcs) on arrival * pathology (white cell count, sodium, calcium, glucose, lactate) * protein s100b and copeptin * seizure characteristics (witnessed, simple, partial, complex, provoked, acute symptomatic, idiopathic) * discharge plan, outcomes follow up at day 7 and day 28, hospital visit or phone call

Eligibility criteria:
inclusion criteria: * seizure within 24 hours of ed attendance * or seizure in the ed exclusion criteria: * pregnancy * prisoner * age \< 18 years old

Keywords: biomarkers emergency department seizures epilepsy s100b copeptin
a study of the recovery benefits after treatment with parecoxib/valdecoxib in patients undergoing abdominal surgery

Conditions: Pain

Summary: the purpose of this study is to evaluate morphine intake in the first 4 hours after abdominal surgery. morphine intake is compared between patients on placebo and patients on parecoxib/valdecoxib.

this study was prematurely terminated because subject recruitment was slower than expected, it was determined that the study was not going to achieve the statistical power necessary to address the primary objective. letters were sent to the sites informing them of study termination on 26 february 2004. the decision to terminate the trial was not based on any safety concerns.

Eligibility criteria:
inclusion criteria: * male or female aged 18 to 65 years weighing at least 50 kg but no more than 110 kg undergoing elective intra-peritoneal laparoscopic abdominal surgery * american society of anaesthesiologists (asa) physical status i-iii exclusion criteria: * significant chronic disease, such as renal, hepatic, cardiovascular, or respiratory, which would contraindicate participation in the study or interfere with interpretation of study results * active gastrointestinal disease, chronic or acute renal or hepatic disorder, or known coagulation defect
dose-escalation safety study of hpn-100 to treat urea cycle disorders

Conditions: Urea Cycle Disorders

Summary: the purpose of this study is to determine whether hpn-100 is safe and tolerable in subjects with urea cycle disorders.

when protein is broken down in the body, nitrogen is formed. in healthy individuals, the body combines this nitrogen with other molecules to create a harmless substance called urea, which is excreted in the urine. patients with urea cycle disorders (ucd) are unable to create as much urea from nitrogen, and therefore, toxic levels of nitrogen can accumulate in the body, causing harm. to treat these patients, doctors usually have the patient consume less protein and supplement certain amino acids that may be lacking. a drug called buphenyl® is sometimes prescribed as an adjunctive treatment for the chronic maintenance of ucd patients in order to keep ammonia levels down. some issues with buphenyl® include a high pill burden (up to 40 pills per day), bad taste and odor, and high sodium content. like buphenyl®, hpn-100 provides an alternate way for the body to dispose of nitrogen, other than through the urea cycle. unlike buphenyl®, hpn-100 is an odorless, tasteless, concentrated oil that does not contain large amounts of sodium. study acquired from horizon in 2024.

Eligibility criteria:
inclusion criteria: * male and female patients at least 18 years old * signed written informed consent by patient or patient's representative * diagnosis of urea cycle enzyme deficiency confirmed via enzymatic or genetic testing * currently treated with buphenyl® tid for a minimum of 2 weeks prior to visit 1 * able to perform study activities (including the ability to collect all urine in the clinic, i.e., no patients in diapers) * negative pregnancy test for all females of childbearing potential. all females of childbearing potential must agree to use an acceptable method of contraception throughout the study exclusion criteria: * use of any investigational drug within 30 days of buphenyl® visit 1 * active infection (viral or bacterial) or any other condition that may increase ammonia levels * laboratory values outside the normal range that are determined to be clinically significant by the investigator * any clinical or laboratory abnormality of grade 3 or greater severity according to the common terminology criteria for adverse events v3.0 (ctcae) (or for conditions not covered by the ctcae, a severe or life-threatening toxicity); except that grade 3 elevations in liver enzymes are allowed in an otherwise clinically stable patient * use of any medication known to significantly affect renal clearance (e.g., probenecid) or to increase protein catabolism (e.g., corticosteroids), or other medication (e.g., valproate) known to increase ammonia levels, within the 24 hours prior to visit 1 * preexisting qtc interval prolongation (\> 450 msec for males or \> 460 msec for females) * other severe chronic medical conditions * known hypersensitivity to paa, pba, or benzoate * creatinine levels equal to or greater than 1.5 × uln * liver transplant

Keywords: buphenyl sodium phenylbutyrate urea cycle disorder ucd
the role of local long acting corticosteroid injection in hypospadias surgery.

Conditions: Hypospadias

Summary: post-operative tissue oedema is one of the main causes of failure of hypospadias repair. severe oedema may disrupt the suture line, invite infection and result in repair failure. thus, we suggested that local injection of corticosteroids in just below coronal sulcus into dartos and buck's fascia may limit this oedema thus improving the outcome of hypospadias repair.

this is a prospective comparative trial : comparing the use of local steroids injection to reduce tissue edema after hypospadias and to preserve the final cosmesis after tissue repair. the patients will be divided into 2 groups(each group 20 patients): one group will be injected steroids just after hypospadias surgery while the other will not. the short and long term outcomes between both groups will be compared.

Eligibility criteria:
inclusion criteria: * hypospadias patient * recurrent cases * 6 months or more * distal, and mid penile hypospadias exclusion criteria: * none

Keywords: hypospadias, edema, failure, fistula, steroids
improved orthostatic tolerance = better cognitive function in parkinson's disease

Conditions: Hypotension, Orthostatic; Parkinson Disease; Autonomic Failure; Cognitive Impairment

Summary: study on orthostatic hypotension in parkinson's disease

orthostatic hypotension (oh) in parkinson's disease (pd) may not only be related to dizziness or light headedness but to deficits in attention, visual, and verbal memory. would a successful treatment of oh which includes physiotherapy significantly improve oh and these cognitive deficits? by means of a randomized cross-over trial, we want to measure and compare the effects of oh therapy on orthostatic tolerance, as well as on attention, visuo-spatial working memory, and verbal memory in patients with pd. if confirmed, therapy of orthostatic hypotension would provide a sound and simple approach to improve those cognitive deficits originating from orthostatic hypotension.

Eligibility criteria:
inclusion criteria: * parkinson's patients * diagnostis of oh * able to perform an ambulatory physiotherapy at aachen university hospital. exclusion criteria: * deep brain stimulation or pacemaker * severe psychiatric disease * severe heart disease * severe vascular encephalopathy * dementia * pregnant or lactating women * extreme pain or immobility
the effects of discontinuation of vitamin k antagonists on the rate of elastin degradation

Conditions: Emphysema or COPD; Aneurysm; Cystic Fibrosis; Alpha 1-Antitrypsin Deficiency

Summary: background: elastin is a unique protein providing elasticity, resilience and deformability to dynamic tissues, such as lungs and vasculature. elastin fibers are characterized by their high affinity for calcium. however, calcified elastin is more prone to the degrading effects of proteases and, in turn, partially degraded elastin has an even higher affinity for calcium. a disturbed balance between proteases and anti-proteases is a major underlying mechanism in the development of chronic obstructive pulmonary disease (copd). virtually the only protein that can protect elastin from calcification is matrix gla-protein (mgp), which needs vitamin k for its activation. in copd patients, a lower vitamin k status is found when compared to control subjects and an inverse association exists between vitamin k status and elastin degradation. in addition, vitamin k status is lower and elastin degradation is accelerated in vitamin k antagonist (vka) users. vkas are widely used. nowadays, an increasing number of patients uses direct oral anticoagulants (doacs), which do not influence vitamin k status. the hypothesis of this study is that discontinuation of vkas results in an improved vitamin k status and deceleration of elastin degradation. in order to test this hypothesis, an observational pilot study will be conducted in which the change in elastin degradation- quantified by plasma desmosine concentrations - in patients who discontinue use of vkas will be used as primary endpoint. study design: observational study. study population: a total of 30 vka users who will discontinue the use of vkas. elastin degradation rate (quantified by plasma desmosine levels) and vitamin k status (quantified by measuring plasma levels of dephosphorylated uncarboxylated (dp-uc)mgp) will be measured during the use of vkas and approximately 6 months after discontinuation of vkas. furthermore, the vkorc1 polymorphisms will be determined. main study parameters: the primary endpoint is the change in the rate of elastin degradation quantified by the plasma desmosine assay. secondary endpoints are the change in vitamin k status quantified by measuring plasma levels of dp-ucmgp, the relation between desmosine and dp-ucmgp and differences of desmosine and dp-ucmgp levels among subjects with different polymorphisms of the vitamin k 2,3-epoxide reductase complex 1 (vkorc1) gene.


Eligibility criteria:
inclusion criteria: * use of vkas for at least 3 months * stop vkas at short time * written informed consent * age ≥18 years * ability to comply with all study requirements exclusion criteria: * active malignancy or cured malignancy \<12 months prior to enrollment * use of maintenance dose oral corticosteroids * serious mental impairment * life expectation of less than 6 months on the basis of concurrent disease
oral fosamprenavir + sodium alginate for gerd

Conditions: Refractory Gastroesophageal Reflux Disease; Gastroesophageal Reflux Disease

Summary: the goal of this clinical trial is to learn if study drug fosamprenavir-sodium alginate (fos-sa) administered orally improves symptoms for proton pump inhibitor (ppi)-refractory gastro esophageal reflux disease (gerd). the main questions it aims to answer are: 1. does fos-sa significantly improve heartburn severity over the 8-week treatment period 2. does fos-sa significantly improve regurgitation frequency over the 8-week treatment period 3. does fos-sa significantly improve symptoms of persistent gerd over the 8-week treatment period researchers will compare fos-sa to a placebo (a look-alike substance that contains no active drug) to see if fos-sa works to treat ppi-refractory gerd. participants will: 1. take fos-sa or placebo every day bid (twice a day) for 8 weeks 2. visit the adult translational research unit (atru) seven times for consenting, screening, and checkups and tests 3. keep a daily diary of their symptoms of persistent gerd


Eligibility criteria:
inclusion criteria: 1. patient aged 18-65 selected as candidate for anti-reflux surgery by study providers. 2. patient has received, and continued having gerd symptoms during, standard-labeled dose, daily, ppi therapy for a minimum of 8 weeks before the screening visit. 3. patient has a diagnosis of gerd with endoscopy and/or ph-metry test within the past two years demonstrating 1 or more of the following: 1. erosive esophagitis (grade a or greater based on the los angeles classification of esophagitis; appendix 3) 2. evidence of pathological acid reflux (ph \< 4 for ≥ 4-6% off therapy or ≥ 1-4% on therapy) during a 24-hour time interval of ph testing 4. patient reports heartburn severity (hs, item #1 on mresq-ed) ≥ 3 (moderate) on at least 2 days and has an average hs of ≥ 2 (mild) during the last 7 days of the pretreatment period before randomization. exclusion criteria: 1. patient is suspected of having, functional upper gastrointestinal disorders such as functional dyspepsia or functional heartburn diagnosed by the rome iv criteria; appendix 4. 2. patient has endoscopically confirmed eosinophilic esophagitis (ee).

Keywords: ppi-refractory gerd proton pump inhibitor refractory gastroesophageal reflux disease fosamprenavir sodium alginate fosamprenavir-sodium alginate fos-sa